Mild Cognitive ImpairmentPCMCItoDNCT01823666
Predicting the Conversion From Mild Cognitive Impairment to Dementia
An observational study of Mild Cognitive Impairment and Alzheimer Disease, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial summary
Mild cognitive impairment (MCI) is believed to be the early stage of dementia. The investigators assume that some psychological and imaging risks may predict the conversion. In the current longitudinal study, psychological and imaging data of people with MCI will be obtained at baseline, and will be followed at 26… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease, Dementia, Vascular
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with cognitive complaint living in the community.
Who may be able to join
- complaint about cognitive decline compared to previous performance
- objective cognitive impairment in one or more cognitive domains for age
- preservation of independence in functional abilities
- Mini-Mental State Examination(MMSE) scores between 24 and 30
- a Clinical Dementia Rating(CDR) score of 0.5
Who cannot join
- dementia
- patient with any following disease: Parkinson's disease, multiple system atrophy, normal pressure hydrocephalus, progressive supranuclear palsy, subarachnoid hemorrhage, brain neoplasms, Huntington disease, epilepsy
- depression(HAMD >7) or psychosis
- uncontrolled severe medical conditions(i.e., acute heart failure, renal insufficiency)
- current treatment with benzodiazepines, antidepressants, antipsychotics, or other medications with significant psychotropic or central cholinergic effects
- abnormal thyroid, low vitamin B12 level or low folic acid level
Show all 9Show fewer
- patient with visual and auditory disorders can't cooperate with neuropsychological assessment
- patient can't cooperate with following up
- informed consent is not obtained
Trial locations and contacts
1 site in 1 country.
China1 site
Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100700
About this study
Official title: Study on Risk Factors for Prediction of Conversion to Dementia in Patients With Mild Cognitive Impairment
Mild cognitive impairment (MCI) is believed to be the early stage of dementia. The investigators assume that some psychological and imaging risks may predict the conversion. In the current longitudinal study, psychological and imaging data of people with MCI will be obtained at baseline, and will be followed at 26 weeks and 52 weeks. The predictors will be found in comparison with controls.
Read the detailed description
MCI increases the risk of later developing dementia. About 10-15% of the amnestic form of mild cognitive impairment will progress to Alzheimer's disease in one year. But some people with MCI never get worse. Others with MCI later have test results that return to normal for their age and education.
To develop a new drug for the prevention of dementia(dementia due to Alzheimer's disease or vascular dementia), investigators need a sensitive and specific tool for recognizing patients who will converse to dementia. The investigators want to establish an operational diagnostic criteria instead of a descriptive criteria for mild cognitive impairment.
- Keywords
- Dementia, Alzheimer's disease, mild cognitive impairment
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia, Vascular, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mild cognitive impairment | People with cognitive complaint will be recruited. Who can be diagnosed as mild cognitive impairment will be enrolled according to the MCI criteria. | |
| Control | Normal cognition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of conversion to dementia
Measured: At baseline, 26 weeks, and 52 weeks.
Secondary outcomes (7)
Mini-Mental State Examination
Measured: At baseline, 26 weeks, and 52 weeks
Immediate and delayed story recall
Measured: At baseline, 26 weeks, and 52 weeks
Clock Drawing Test(CDT)
Measured: At baseline, 26 weeks, and 52 weeks
Boston Naming Test
Measured: At baseline, 26 weeks, and 52 weeks
Verbal Category Fluency Test(animals)
Measured: At baseline, 26 weeks, and 52 weeks
Trail Making Test(TMT)
Measured: At baseline, 26 weeks, and 52 weeks
Hopkins Verbal Learning Test(HVLT)
Measured: At baseline, 26 weeks, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startSep 2012
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinzhou Tian, Dongzhimen Hospital, Beijing
- Investigators
- Jinzhou Tian, Doctor, Principal investigator, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823666
- Sponsor's protocol ID
- Z11107056811043
- Acronym
- PCMCItoD
- Status last verified
- Aug 2021
- First submitted
- 30 Mar 2013
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ni J, Shi J, Wei M, Tian J, Jian W, Liu J, Liu T, Liu B. Screening mild cognitive impairment by delayed story recall and instrumental activities of daily living. Int J Geriatr Psychiatry. 2015 Aug;30(8):888-90. doi: 10.1002/gps.4317. No abstract available.
PubMed 26172064
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Risk Factors for Prediction of Conversion to Dementia in Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01823666
- Acronym / sponsor ID
- PCMCItoD / Z11107056811043
- Keywords
- Dementia, Alzheimer's disease, mild cognitive impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mild cognitive impairment (MCI) is believed to be the early stage of dementia. The investigators assume that some psychological and imaging risks may predict the conversion. In the current longitudinal study, psychological and imaging data of people with MCI will be obtained at baseline, and will be followed at 26 weeks and 52 weeks. The predictors will be found in comparison with controls.
Detailed description
MCI increases the risk of later developing dementia. About 10-15% of the amnestic form of mild cognitive impairment will progress to Alzheimer's disease in one year. But some people with MCI never get worse. Others with MCI later have test results that return to normal for their age and education.
To develop a new drug for the prevention of dementia(dementia due to Alzheimer's disease or vascular dementia), investigators need a sensitive and specific tool for recognizing patients who will converse to dementia. The investigators want to establish an operational diagnostic criteria instead of a descriptive criteria for mild cognitive impairment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild cognitive impairment | – | –People with cognitive complaint will be recruited. Who can be diagnosed as mild cognitive impairment will be enrolled according to the MCI criteria. |
| Control | – | –Normal cognition. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with cognitive complaint living in the community.
Key inclusion criteria (5 listed)
- complaint about cognitive decline compared to previous performance
- objective cognitive impairment in one or more cognitive domains for age
- preservation of independence in functional abilities
- Mini-Mental State Examination(MMSE) scores between 24 and 30
- a Clinical Dementia Rating(CDR) score of 0.5
Key exclusion criteria (9 listed)
- dementia
- patient with any following disease: Parkinson's disease, multiple system atrophy, normal pressure hydrocephalus, progressive supranuclear palsy, subarachnoid hemorrhage, brain neoplasms, Huntington disease, epilepsy
- depression(HAMD >7) or psychosis
- uncontrolled severe medical conditions(i.e., acute heart failure, renal insufficiency)
- current treatment with benzodiazepines, antidepressants, antipsychotics, or other medications with significant psychotropic or central cholinergic effects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of conversion to dementia
Time frame: At baseline, 26 weeks, and 52 weeks.
7 secondary outcomes
Mini-Mental State Examination
Time frame: At baseline, 26 weeks, and 52 weeks
Immediate and delayed story recall
Time frame: At baseline, 26 weeks, and 52 weeks
Clock Drawing Test(CDT)
Time frame: At baseline, 26 weeks, and 52 weeks
Boston Naming Test
Time frame: At baseline, 26 weeks, and 52 weeks
Verbal Category Fluency Test(animals)
Time frame: At baseline, 26 weeks, and 52 weeks
Trail Making Test(TMT)
Time frame: At baseline, 26 weeks, and 52 weeks
Hopkins Verbal Learning Test(HVLT)
Time frame: At baseline, 26 weeks, and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Derived from this study: PubMed 26172064Ni J, Shi J, Wei M, Tian J, Jian W, Liu J, Liu T, Liu B. Screening mild cognitive impairment by delayed story recall and instrumental activities of daily living. Int J Geriatr Psychiatry. 2015 Aug;30(8):888-90. doi: 10.1002/gps.4317. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinzhou Tian, Doctor principal investigator
Dongzhimen Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Alzheimer Disease, run by Dongzhimen Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of conversion to dementia (time frame: At baseline, 26 weeks, and 52 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01823666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.